MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the permanent cautery hook's black protector came loose.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) has contacted the customer to request additional information.However; no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed the reported complaint of "black protector or hook came loose".The instrument was found to have a broken ceramic sleeve and a broken piece was missing as a result of breakage.The ceramic sleeve is observed to be dislodged, likely due to the breakage.The size of the missing piece is approximately 0.077¿ x 0.060¿.The root cause of broken instrument ceramic sleeve is typically attributed to the user mishandling, such as excess force applied to the distal end of the instrument or accidental collisions.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.An instrument log review was performed.It was confirmed that the permanent cautery hook instrument involved with this complaint was used on 2/17/2022 with system sk0871.The instrument was used for 58 minutes, and had 7 uses remaining out of a total of 10 uses.There was no image or video clip submitted for review.Based on the additional information obtained from failure analysis investigations, this complaint is being reported as a reportable malfunction due to the following conclusion: failure analysis acknowledges that a broken piece was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14120861
• MDR Text Key: 298786022
• Report Number: 2955842-2022-11070
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)210409(10)N12210412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N12210412 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES